BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SIEMENS-ELEMA PSA 376

    K Number: K812104 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    66
    Review Days
    131

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    Basic Information

    Device Name
    SIEMENS-ELEMA PSA 376
    K Number
    K812104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Siemens Corp.
    Date Received
    July 24, 1981
    Decision Date
    December 2, 1981
    Product Code
    DTA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTA Tester, Pacemaker Electrode Function

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